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Guideline on aspects of the application of Article 8(1) and (3) of Regulation (EC) No 141/2000: Assessing similarity of medicinal products versus authorised orphan medicinal products benefiting from market exclusivity and applying derogations from that market exclusivity
Publikācijas metadati
- Publicēts:
- Autoru kolektīvs: Council of the European Union , European Parliament
- Temats: application of EU law , derogation from EU law , drugs classification , exclusive distribution agreement , market approval , medicinal product , pharmaceutical legislation
- CELEX : 52008XC0923(03)
- OJ : JOC_2008_242_R_0012_01
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